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CERAMENT™|G - Bone Healing and Re-infection Prophylaxis

NCT ID: NCT02128256

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-05-31

Brief Summary

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The surgical management of long bone infections is often challenging. Adequate surgical debridement decreases the bacterial load, removes dead tissues, and gives a chance for the host immune system and antibiotics to arrest infection. Adequate debridement may leave a large bony defect. An appropriate management of the dead space is essential to arrest the disease, and for maintenance of the bone's integrity. The current strategy includes the use of antibiotic-loaded bone cement that can be used to sterilize and temporarily maintain the dead space. The cement are usually removed after 2 to 4 weeks and replaced with a cancellous graft harvested from the hip of the patient.

CERAMENT™\| G is a CE-marked resorbable ceramic bone graft substitute composed by calcium sulfate and calcium hydroxyapatite, intended to fill gaps and voids in the skeleton system and to promote bone healing. The antibiotic gentamicin is included in the ceramic to prevent colonization of gentamicin-sensible microorganisms in order to protect bone healing.

The aim of this study is to investigate the device absorption and bone in-growth of CERAMENT™\| G in a surgically revised bone infection. In addition, bone healing and infection non-recurrence will be evaluated during 12 months of follow-up. The investigators expect a treatment success of \>90 % and that a similar bone healing will be obtained as with a standard two-stage surgical procedure. In addition, the investigators believe that the use of CERAMENT™\| G will be of advantage for the patient as bone healing will be achieved with a one-stage surgical procedure (in combination with antibiotic therapy), instead of a two-stage procedure, thus decreasing potential surgery-related complications.

Detailed Description

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Conditions

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Osteomyelitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cerament G injection

Cerament G is injected to fill a bone defect after debridement of the infected bone.

Group Type EXPERIMENTAL

Cerament G

Intervention Type DEVICE

Interventions

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Cerament G

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with a long bone infection in femur, tibia, humerus or radius
* Candidate for one stage procedure
* Patients above the age of 18
* Written informed consent obtained before any study-related activities
* Patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program

Exclusion Criteria

* Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
* Hypersensitivity to aminoglycoside antibiotics
* Myasthenia gravis
* Severe renal impairment
* Pre existing calcium metabolism disorder.
* Women who are pregnant or breastfeeding (a pregnancy test will be done in women of childbearing potential)
* History of hypersensitivity to the investigational device or any of its ingredients
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Olivier Borens

OTHER

Sponsor Role lead

Responsible Party

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Dr. Olivier Borens

Head of Service of Traumatology and Septic Surgical Unit

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Lausanne University Hospital, Service of Orthopedy and Traumatology

Lausanne, Canton of Vaud, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Olivier Borens, MD

Role: CONTACT

[email protected]
00 41 21 314 27 89

Facility Contacts

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Olivier Borens, MD

Role: primary

[email protected]
00 41 21 314 27 89

Other Identifiers

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CeramentG-CH-2014

Identifier Type: -

Identifier Source: org_study_id